Crohn's Disease enteritis regionalis
Conditions
Interventions
The study is compromised of a 12-week double-blind, placebo-controlled
induction period, followed by either a 12-week double-blind re-induction period
for non-responders or a 40-week double-blind pl
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male or female between 18 and 75 years of age inclusive at the time of Screening. 2. Confirmed diagnosis of CD for at least 3 months prior to Baseline of the Induction Period. 3. CDAI score 220 to 450 at Baseline of the Induction Period. 4. Endoscopic evidence of mucosal inflammation as documented by an SES-CD of >= 6 for ileocolonic or colonic disease or SES-CD of >= 4 for isolated ileal disease as scored by a central reader. All eligible scores must exclude the presence of narrowing component. 5. Demonstrated intolerance or inadequate response to one or more of the following biologic agents: infliximab, adalimumab, certolizumab pegol, vedolizumab, natalizumab, or ustekinumab.
Exclusion criteria
Exclusion criteria: 1. Subjects with prior intolerance to adalimumab are not eligible to enroll. 2. Subjects who discontinued biologic agents only for reasons other than inadequate response or intolerance (e.g., change of insurance) are not eligible to enroll.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the achievement of endoscopic response at Week 12 in the Induction Period defined as a decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD17) > 50% from Baseline (or for subjects with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Achievement of clinical remission per Crohn's Disease Activity Index (CDAI) at Week 12 in the Induction Period defined as CDAI | — |
Countries
Netherlands
Outcome results
None listed